A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
Public ClinicalTrials.gov record NCT00000658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Study identification
- NCT ID
- NCT00000658
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
- Bleomycin sulfate Drug
- Vincristine sulfate Drug
- Doxorubicin hydrochloride Drug
- Cyclophosphamide Drug
- Allopurinol Drug
- Methotrexate Drug
- Cytarabine Drug
- Leucovorin calcium Drug
- Sargramostim Drug
- Dexamethasone Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Feb 1996 (Actual)
- Last update posted
- Nov 3, 2021
Ends 1996
United States locations
- U.S. sites
- 22
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC CRS | Los Angeles | California | 900331079 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90095 | — |
| Ucsf Aids Crs | San Francisco | California | 941102859 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 462025250 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | — | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | — |
| Bmc Actg Crs | Boston | Massachusetts | — | — |
| Washington U CRS | St Louis | Missouri | — | — |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 14215 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 02215 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Memorial Sloan-Kettering Cancer Ctr. | New York | New York | 10021 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Case CRS | Cleveland | Ohio | — | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000658 live on ClinicalTrials.gov.